By Jane Mundy, forlawyersandsettlements.com.
Surgical stapler lawsuits aimed at medical device manufacturers claim that these defective surgical staplers have caused serious injuries—for many years: The majority of complications were concealed from the public by the FDA in a “hidden database” and have just recently been made public.
DEFECTIVE SURGICAL STAPLERS
Surgical staplers, also known as sutures for minimally invasive surgeries, are used to save time during surgery and supposedly reduce the risk of anesthesia complications. Their purpose is to both cut tissue and vessels and then quickly seal them. But serious complications can occur by firing defective staples into organs or other tissue. Surgical stapler injury can also occur by not firing all the staples necessary to seal an incision, which can cause bleeding and other complications. Defective surgical stapler reports include staplers that have created holes in the tissues without leaving staples behind, or staplers that have failed to close the implanted staples.
If the surgical stapler is defective, the repair it is supposed to secure could break loose and cause the contents of an organ that is undergoing repair to be released into the surrounding body.
The ECRI Institute, an independent non-profit health safety group, identified misuse of surgical staplers as a top health technology concern. In its “Top 10 Technology Hazards Report” surgical stapler misuse and malfunction ranks Number 1.
“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”
SURGICAL STAPLER RISKS AND COMPLICATIONS
Patients have been seriously injured when staplers have failed to fire or seal tissue, causing internal bleeding, organ damage and/ or infections or death when used during surgeries. Reported complications include severe infections, cardiac problems, and the need for corrective surgeries. One patient required several additional surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his bowel. Another patient reported that her intestines were punctured when a Medtronic EEA surgical stapler allegedly misfired during her surgery.
SURGICAL STAPLERS AND FDA “SECRET” DATABASE
It took a Kaiser Health News report in 2019 for the FDA to release its hidden database and tighten regulations around surgical staplers. The agency admitted in a letter to doctors (March 2019) that it received more than 56,000 surgical stapler malfunction reports from 2011 through 2018 but chose not to inform doctors, hospitals or the public.
In April 2019 the FDA toughened regulations and proposed reclassifying surgical staplers from low-risk to moderate-risk devices, which meant a stricter approval process. (Surgical staplers were in the same category as simple devices like tongue depressors and bandages.) At the same time, labeling changes included proper use and safety hazards. The agency then asked for expert input on its analysis of all reported injuries and less than two months after toughening regulations, it warned to doctors and hospitals of the high number of deaths and injuries related to staplers.
Of the 41,000 malfunctions reported to the MAUDE public database, at least 366 deaths and more than 9,000 serious injuries were related to surgical staplers over eight years—from 2011 until early 2019. But the FDA posted less than 100 stapler-related injury reports to the public MAUDE database in 2016.
The FDA in May 2019 published an analysis of 109,997 stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. According to MAUDE, deaths were associated with Ethicon and Covidien (a division of Medtronic) products.
Medtronic and Johnson & Johnson’s Ethicon are the two biggest surgical stapler makers. Medtronic said the FDA granted it exemptions for stapler-related malfunctions, but J&J said it had not.
SURGICAL STAPLER LAWSUITS
In lawsuits filed against Medtronic and Covidien, plaintiffs blame the manufacturers for serious health complications, claiming that the staplers were defectively designed and manufactured. Medtronic has been blamed for failure to warn doctors and patients of the potential dangers.
At least three lawsuits filed in late 2017 against Medtronic involve patients who underwent gastrointestinal surgeries that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned by creating holes without leaving behind staples or not properly closing implanted staples.
One of those lawsuits filed against Medtronic states that “A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body.”
Another patient sued Medtronic after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to several infections, more surgical treatments a serious complication called an anastomotic leak.
THE FDA AND MEDTRONIC ASR REPORTS
The FDA hid from the public 10,000 reports as so-called “alternative summary” reports according to Kaiser Health News.
The above plaintiffs all say Medtronic intentionally used a secret loophole in federal adverse-event reporting laws that allowed it to conceal the true risks from the device by burying injury reports in nonpublic files known as alternative summary reports (ASRs). “By doing so, [Medtronic) intentionally concealed from public view the many injuries caused by the use of its Endo GIA staplers,” one lawsuit says.
Federal law requires med-tech companies like Medtronic and Covidien, the staplers’ maker before Medtronic acquired the company in 2015 — to file a public report with the FDA anytime anyone at the company learns that “any of their devices may have caused or contributed to a death or serious injury,” says the FDA. “Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
However, until 2019 the FDA’s ASR program allowed manufacturers to secretly file spreadsheets summarizing large numbers of adverse events with little to no supporting detail, in cases in which the FDA agreed with the manufacturer that the adverse events were “well-known and well-established risks associated with a particular device,” reported the Star Tribune. Back in 2016, the Tribune reported that Medtronic was a prolific user of the virtually unknown ASR system, but the following year—once this information was made public– the number of ASR reports filed with the FDA declined steeply, FDA filings show. Following critical reports in other media outlets, the agency eliminated the program in 2019.
SURGICAL STAPLER RECALLS
In May 2019, Medtronic recalled a number of its Ethicon Endo-Surgery Staplers, identifying it as a Class 1 recall, the most serious type. The recall said a missing pin in devices distributed since 2014 could lead to problems, including anastomotic leak. In October 2019, Ethicon recalled the Echelon Flex Powered Plus Endopath 60mm Stapler, due to the potential for malfunction.
An attorney for one of the plaintiffs said in late 2019 that these lawsuits might spur the beginning of litigation against Medtronic regarding the way it sells and reports safety information on its now-recalled staplers.
ONGOING SURGICAL STAPLER LITIGATION
The largest surgical stapler lawsuit verdict was $80 million for a woman who suffered injuries during surgery that nearly killed her. Due to recalls, reclassification, and increased public awareness of these defective devices being hidden from the public, attorneys predict an increase in surgical stapler lawsuits.